In the News
Bayer to acquire UK-based biotech KaNDy Therapeutics Ltd.
Further expansion of Bayer’s drug development pipeline in Women’s Healthcare
Upfront consideration of USD 425 million and additional potential consideration in the form of milestone payments
Bayer, a global leader in women’s healthcare, and KaNDy Therapeutics Ltd, a UK clinical-stage biotech company, today announce that Bayer will acquire KaNDy Therapeutics Ltd. to expand its drug development pipeline in women’s healthcare.
Under the terms of the agreement Bayer will pay an upfront consideration of USD 425 million, potential milestone payments of up to USD 450 million until launch followed by potential additional triple digit million sales milestone payments. Closing is subject to customary conditions, in particular anti-trust approval, and is expected by September 2020.
The acquisition of KaNDy Therapeutics Ltd. is another important milestone in augmenting Bayer’s own women’s healthcare portfolio through strategic collaborations and agreements.
Morgan Stanley is serving as financial advisor to Bayer, while Linklaters is serving as legal counsel. Goldman Sachs International is serving as financial advisor to KaNDy Therapeutics Ltd., while Goodwin is serving as legal counsel.
Bayer Contact:
Phone +44 (0)118 206-3977
Email: communications.ukireland@bayer.com
KaNDy Therapeutics Ltd. Contact:
Phone +44 (0)7885 715 857
Email: kandyTherapeutics@consilium-comms.com
Inotrem receives clearance from French, Belgian and US authorities to launch a Phase II clinical trial aimed at assessing nangibotide in mechanically ventilated patients with COVID-19
Inotrem’s clinical study on Covid-19 was selected by the French government to be part of its €78 M action plan aimed at reinforcing the countries’ research capabilities for therapeutic solutions.
Pre-clinical studies have demonstrated that nangibotide has a positive effect on controlling inflammatory syndromes and restores an appropriate immune response by targeting the TREM-1 pathway which is activated in patients suffering from COVID-19.
Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway, announced today that it has obtained authorization to launch its phase IIa clinical trial in COVID-19 patients in France, Belgium and the USA.
For this study, Inotrem received a non-dilutive funding as part of the call for proposals PSPC Covid, financed by the Investments d’Avenir Program which managed on behalf of the French government by Bpifrance, France’s public investment bank. Inotrem with its partners the CHRU of Nancy and the CHU of Limoges, was one of the 6 French biotech companies who benefited from this programme to support the research and development of therapeutic solutions targeting COVID-19.
The goal of this first exploratory study is to determine the safety and tolerability and potential signals of efficacy of nangibotide in critically ill patients with COVID-19 with inflammatory syndromes. The objective of this project is to have a positive impact on the severity of the respiratory failure, reduce duration of mechanical ventilation, length of stay in ICU and reduce mortality. Sixty patients will be enrolled in Europe and in the United States. This study follows an observational study in 27 patients, conducted by Prof. Sébastien Gibot at the CHRU of Nancy, which showed an increased expression of the TREM-1 pathway in severe COVID-19 patients. TREM-1 is an immunomodulatory receptor expressed on innate immune cells which amplifies and maintains inflammation.
Previous clinical studies with nangibotide demonstrated its safety and tolerability in patients suffering from septic shock, which is also characterized by an acute inflammatory syndrome. Pre-clinical models have shown that nangibotide inhibits the amplification of the immune response caused by the activation of TREM-1 and was able to restore appropriate inflammatory response, vascular function, and improved survival in septic shock models. Inotrem is currently conducting a Phase IIb trial (ASTONISH) to treat septic shock patients with nangibotide in 6 European countries and the United States. It is also developing, with Roche Diagnostics, a companion diagnostic test to identify patients more likely to benefit from its nangibotide treatment. Coronavirus disease 2019 is a new pandemic disease that arises as a consequence of infection with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The optimum treatment strategy in the management of critically ill patients with COVID-19 continues to evolve and, in addition to supportive therapies such as mechanical ventilation, vasopressors and renal replacement therapy, may include immunomodulatory approaches, such as nangibotide, in patients with severe disease.
Professor Sébastien Gibot, Nancy University Hospital and coordinating investigator said “We observed that the TREM-1 pathway was activated in severe forms of COVID-19. Nangibotide is a TREM-1 inhibitor and has the potential to restore an appropriate immune response. We are hoping to demonstrate that nangibotide will reduce the duration of hospitalization and mortality of critically ill patients suffering from COVID-19”.
Jean-Jacques Garaud, CEO of Inotrem, declared: “We are very pleased with both the granting of this financial support and the clearance to start our clinical trial. The French administration has been very effective in working in a coordinated and rapid fashion.”
About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors. www.inotrem.com
About TREM-1 pathway
TREM-1 pathway is an amplification loop of the immune response that triggers an exuberant and hyperactivated immune state which is known to play a crucial role in the pathophysiology of septic shock and acute myocardial infarction. Today, there is an increasing number of publications indicating that the TREM-1 pathway is also implicated in chronic inflammatory diseases.
About Nangibotide
Nangibotide is the formulation of the active ingredient LR12, which is a 12 amino-acid peptide prepared by chemical synthesis. LR12 is a specific TREM-1 inhibitor, acting as a decoy receptor and interfering in the binding of TREM-1 and its ligand. In preclinical septic shock models, nangibotide was able to restore appropriate inflammatory response, vascular function, and improved animals’ survival post septic shock.
About ASTONISH Study
The Efficacy, Safety and Tolerability of nangibotide in Patients with Septic Shock (ASTONISH) phase IIb trial is a Randomized, Double-blind, Placebo Controlled Dose Selection Study that will be performed Europe and the US. Four hundred and fifty patients are planned to be included in this study in 48 clinical sites. The study will compare the effect of nangibotide at two different doses versus standard of care.
About Bpifrance
Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extrafinancial services (training, consultancy.). to help entrepreneurs meet their challenges (innovation, export…). For more information, please visit: www.bpifrance.fr and presse.bpifrance.fr - Follow us on Twitter: @Bpifrance - @BpifrancePresse
About French Strategic Investment Program
Endowed with 57 billion euros, the “French Strategic Investment Program” (PIA), lead by the General Secretary for Investment under the authority of the Prime minister, has been implemented to finance innovative and promising investments all over the territory, in order to allow France to increase its potential for long-term growth and jobs creation. The third component of the PIA, endowed with 10 billion euros, is part of the 57 billion euros Grand Plan d’Investissement (GPI) committed by the Government in 2017 and for a five years period in order to support structural reforms and respond to four major challenges in France : carbon neutrality, better access to employment, competitiveness through innovation and building the digital state.
Media contact for Inotrem
Anne REIN
S&I
anne.rein@strategiesimage.com
+33 6 03 35 92 05
FDA Grants Orphan Drug Designation for Inflazome’s Inzomelid for the Treatment of Cryopyrin-Associated Periodic Syndromes (CAPS)
Inzomelid is a potent, selective, orally-available, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases.
Inflazome announced positive Phase Ib results with Cryopyrin-Associated Periodic Syndrome (CAPS), an autoinflammatory orphan disease driven by a mutated NLRP3 inflammasome, earlier this year.
Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Inzomelid in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS).
Orphan Drug Designation is an important regulatory milestone granted to drugs that are intended to treat rare diseases and conditions, such as CAPS. CAPS is a rare, autoinflammatory orphan disease driven by a mutation affecting the NLRP3 inflammasome. Activation of the NLRP3 inflammasome is implicated in many diseases caused by chronic, harmful inflammation. Inflazome is looking to address such inflammation with one of its investigative drugs, Inzomelid, a potent and selective inhibitor of the NLRP3 inflammasome that can be taken orally.
In March 2020, Inflazome announced positive results with Inzomelid in CAPS, alongside the completion of a broader Phase I study that demonstrated excellent safety, tolerability and pharmacokinetics in healthy subjects. A follow-on Phase II trial is planned for this year to develop the dose for CAPS patients.
Dr. Thomas Jung, Chief Medical Officer, Inflazome, commented, “Receiving Orphan Drug Designation from the FDA is a validation of one of our investigative drugs, Inzomelid, and the pioneering work that we have done with the NLRP3 inflammasome since our foundation. Activation of NLRP3 is implicated in a very wide spectrum of diseases, of which CAPS is just one. Today’s news is a positive development for the CAPS patient community, for whom there are currently limited treatment options. We look forward to further developing Inzomelid and initiating our Phase II study in CAPS later this year.”
About Inflazome
Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH.
Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions.
Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.
About Cryopyrin-associated periodic syndromes
Cryopyrin-associated periodic syndromes (CAPS), also called cryopyrin-associated autoinflammatory syndromes, are three diseases related to a defect in the NLRP3 gene. CAPS encompasses neonatal onset multisystem inflammatory disease (NOMID), Muckle-Wells syndrome (MWS) and familial cold autoinflammatory syndrome (FCAS). The differences in these diseases lie in their severity and the organs involved.
About Orphan Drug Designation
The Orphan Drug Designation Program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.
Mainstay Medical Announces U.S. FDA Approval of ReActiv8® Neurostimulation System for Chronic Low Back Pain
U.S. commercialization expected to begin in the first half of 2021
Continues positive momentum for Mainstay, with increasing commercial footprint in Europe and expected launch in Australia in early 2021
Mainstay Medical Holdings plc (“Mainstay” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Premarket Approval (PMA) application for ReActiv8®, its implantable neurostimulation system to treat intractable chronic low back pain.
Jason Hannon, CEO of Mainstay, said: “I am so proud of our team and the dedicated physicians who managed our clinical trials and cared for their patients. We are thrilled to receive FDA approval of ReActiv8, which is designed to be a restorative treatment and represents a new option for patients suffering with chronic low back pain. This disease affects millions of people around the world, and our clinical data demonstrates that ReActiv8 therapy provides progressive improvements in pain and disability over time, both in magnitude of effect and the proportion of patients who benefit from the treatment. This therapy has the potential to improve quality of life for the most severely-affected patients, and we look forward to making it available to U.S. patients and physicians beginning in the first half of 2021. This will build upon our growing business in Europe and our upcoming launch in Australia.”
“This milestone is the culmination of a development process over many years,” continued Mr. Hannon. “I would like to thank every member of our team, past and present, and in particular our clinical investigators, their teams and clinical study patients for their support and contributions.”
Dr. Chris Gilligan, Chief, Division of Pain Medicine, Department of Anaesthesiology, Perioperative and Pain Medicine, Brigham & Women’s Hospital, Assistant Professor of Anaesthesia, Harvard Medical and Principal Investigator of the pivotal ReActiv8-B study, said: “ReActiv8 fills an important unmet clinical need of patients suffering from chronic low back pain. Patients indicated for ReActiv8 therapy have generally tried numerous other treatments, including physical therapy and pain medications, and many are on long-term opioids to manage their pain. I have seen ReActiv8 provide durable improvements in back pain, the disabling effects of back pain, and quality of life. I am proud to have served as Principal Investigator of this landmark trial, and I look forward to sharing this experience with my physician colleagues who want to start using ReActiv8 in their patients.”
Dr. Robert Levy, a prominent neurosurgeon and pioneer in the field of neuromodulation, commented: “ReActiv8 represents a new treatment category for this severely-affected patient population. The use of neuromodulation to target underlying functional and motor-control issues in patients with musculoskeletal back pain can address a large unmet clinical need. ReActiv8 is designed as a restorative therapy for those suffering from musculoskeletal pain and does not compete with other forms of neuromodulation such as spinal cord stimulation. These patients are difficult for clinicians to treat with current therapy options, which is why so many of them take opioids to manage their pain. Having been part of the neuromodulation field for so long, I am really impressed by this particular innovation and I look forward to its adoption in clinical practice.”
The FDA approval grants Mainstay the right to market ReActiv8 in the United States as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.
The FDA approval of ReActiv8 is primarily based on results from the ReActiv8-B clinical study, a pivotal 204-patient, international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from FDA.
Based on the FDA approval, Mainstay is refining its commercial launch plans for ReActiv8 in the U.S., including the build out of the commercial team, inventory procurement and related matters, as well as evaluating the financial resources necessary to fund its planned activities. Mainstay intends to host an investor event later this year to provide an update on its commercial plans for ReActiv8.
About ReActiv8®
ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 provides bilateral electrical stimulation of the L2 medial branch of the dorsal ramus nerve as it crosses the transverse process at L3. This nerve supplies the lumbar multifidus muscle, a key stabilizing muscle of the low back. Reactiv8’s stimulation of the nerve elicits contraction of the muscle, which can lead to improvement in CLBP and its disabling effects.
Low back pain is the number one cause of years lived with disability worldwide and a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which merely mask the pain. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company currently estimates that there are approximately two million people in the EU and the U.S. who could be candidates for ReActiv8.
ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. ReActiv8 has also been admitted to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia, and has been approved for inclusion on the Protheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. In the U.S., ReActiv8 is FDA approved, and the Company plans to commercially launch in early 2021.
About Mainstay Medical Holdings
Mainstay Medical Holdings is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands.
About the ReActiv8-B Clinical Trial
Mainstay submitted the PMA application to the FDA based upon the totality of its clinical data for ReActiv8. The pivotal clinical trial upon which the PMA submission was based is the ReActiv8-B study. The ReActiv8-B clinical trial is an international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an Investigational Device Exemption (IDE) from the FDA. A total of 204 patients with chronic low back pain refractory to physical therapy and medical management were implanted with ReActiv8 at leading clinical sites in the U.S., Europe and Australia and randomized 1:1 to therapy or control. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit episodic contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed over to receive levels of electrical stimulation similar to those in the treatment group. Information about the study can be found at https://clinicaltrials.gov/ct2/show/study/NCT02577354.
About Chronic Low Back Pain
One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing for improvement in CLBP and its disabling effects.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.
Further information can be found at www.mainstay-medical.com
Mainstay Medical Announces Reimbursement Approval for ReActiv8 in Australia
Mainstay Medical Holdings plc (“Mainstay” or the “Company”), today announced that ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, has been approved for inclusion in the Prostheses List of reimbursed products in Australia, effective as of 1 July 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia. This approval follows the December 2019 regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, which confirmed the inclusion of ReActiv8 in the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.
Jason Hannon, CEO of Mainstay, said: “We continue to demonstrate the clinical value of ReActiv8 to patients suffering from Chronic Low Back Pain. Our growing body of evidence from clinical studies performed to date, as well as our early commercial experience in Germany, shows the substantial restorative benefits patients are receiving. We are delighted to be included in the Prostheses List, enabling us to deliver this valuable therapy to Australian physicians and patients. Several top Australian physicians have been part of our clinical studies since inception and are among the most experienced globally in selecting and treating patients with ReActiv8. We look forward to providing commercial availability of ReActiv8 to these physicians and their peers across Australia, which we intend to begin in early 2021.”
About ReActiv8
ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 electrically stimulates the nerves that supply the lumbar multifidus muscle, a key stabilizing muscle of the low back, to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.
Low back pain is the number one cause of years lived with disability worldwide and is a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry, and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predominantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which offer temporary relief at best. ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company estimates that there are approximately two million people in the EU and the U.S. alone who could be candidates for ReActiv8 today.
ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. The Company submitted the final module of its Pre-Market Approval (PMA) application to the U.S. FDA relating to ReActiv8 in August 2019, and it expects an approval decision around the end of 2020.
Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS)
The Phase I study demonstrated Inzomelid has an excellent safety, tolerability and pharmacokinetic profile in healthy subjects, with dose-dependent target engagement
Inzomelid also delivered positive preliminary results from a patient with Cryopyrin-Associated Periodic Syndrome (CAPS)
Inzomelid is a potent, selective, brain-penetrant NLRP3 inflammasome inhibitor intended for treatment of debilitating inflammatory diseases of the brain and is expected to move into Phase II trials this year
Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces the successful completion of a Phase I study of Inzomelid, alongside positive results from a Cryopyrin-Associated Periodic Syndrome (CAPS) patient dosed with Inzomelid. CAPS is an autoinflammatory orphan disease driven by mutated NLRP3. The results support the progression of Inzomelid into Phase II clinical trials.
Inzomelid is a selective, orally available small molecule inhibitor of the NLRP3 inflammasome. Activation of the NLRP3 inflammasome is implicated in many diseases caused by chronic, harmful inflammation.
Drug exposures in the double blinded and randomised Phase I trial in healthy subjects increased linearly with dose, and correlated with markers of target engagement. The drug also demonstrated an excellent safety and tolerability profile.
Preliminary analysis from the CAPS part of this study showed that a patient with a confirmed NLRP3 mutation suffering from a CAPS-related flare showed rapid clinical improvement within hours and remission within days. A follow-on Phase II trial is planned to identify the best dose for CAPS patients.
Inzomelid follows Inflazome’s other NLRP3 inflammasome inhibitor, Somalix, in successfully completing Phase I trials. Somalix, an orally available, peripherally-restricted drug for inflammatory diseases, also demonstrated excellent safety, tolerability and pharmacokinetics in healthy subjects and is expected to enter Phase II trials in 2020.
Dr. Thomas Jung, Chief Medical Officer of Inflazome, commented, “The positive Phase I results from our two lead candidates, Inzomelid and Somalix, further validate our technology platform as we head with real momentum towards multiple Phase II trials later this year. The Inzomelid CAPS data also represents a very exciting step for the field in orphan indications. We believe this is the first example of positive data in a human disease setting with a small-molecule NLRP3 inhibitor. Our primary motivation is to develop drugs for which a high unmet medical need exists, so we are pleased to see that Inzomelid has demonstrated clear clinical potential.”
About Inflazome
Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.
About Cryopyrin-associated periodic syndromes
Cryopyrin-associated periodic syndromes (CAPS), also called cryopyrin-associated autoinflammatory syndromes, are three diseases related to a defect in the NLRP3 gene. CAPS encompasses neonatal onset multisystem inflammatory disease (NOMID), Muckle-Wells syndrome (MWS) and familial cold autoinflammatory syndrome (FCAS). The differences in these diseases lie in their severity and the organs involved.
Neuromod Appoints Florian Elsaesser as Chief Commercial Officer
Advances Commercialisation of Tinnitus Treatment Lenire™
Neuromod Devices Limited (“Neuromod” or “The Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, is pleased to announce that Mr. Florian Elsaesser has been appointed as Chief Commercial Officer.
Mr. Elsaesser, a hearing aid industry expert, has worked in the sector for over 12 years in various executive positions for Sivantos and Siemens Audiology. Prior to Siemens Audiology’s acquisition by Private Equity fund EQT, Florian held senior financial roles managing global functions in finance and controlling. After the acquisition, Florian went on to hold senior business development and marketing roles in the newly rebranded Sivantos. In these roles, he managed the acquisition and integration of companies and coordinated global sales and marketing functions. Florian holds a Master's degree in Economics from Technische Universität Berlin and graduated in Management from the renowned Ecole Supérieure de Commerce de Paris (ESCP).
Mr. Elsaesser's appointment follows the completion of two of the largest and longest followed up clinical trials ever conducted in tinnitus, including 517 participants. Mr. Elsaesser will be responsible for advancing the commercialisation of the Neuromod’s breakthrough tinnitus treatment product - Lenire™.
The Company is working towards the European commercialisation of Lenire®; scaling up manufacturing capacity to meet anticipated European demand; and progressing US regulatory strategy to secure market entry into the United States. Mr. Elsaesser will play a key role in these developments.
Welcoming the appointment, Dr. Ross O’Neill, CEO of Neuromod said: “I am delighted to announce that Florian Elsaesser will be joining the Neuromod team as Chief Commercial Officer. Attracting a leading hearing aid industry expert with extensive experience across the sector is an exciting development and recognition of the immense potential of our technology. It is a pivotal time for the Company as we progress with European commercialisation of Lenire™. Florian’s experience will be crucial as we work towards delivering our much-anticipated breakthrough treatment to people currently living with tinnitus.”
Mr. Elsaesser added: "With Lenire™ Neuromod has developed a fantastic treatment option for the millions of tinnitus sufferers globally whose clinical needs remain under served. Lenire™ has achieved compelling results in multiple large-scale clinical trials. Personally, I am excited about the high overlap between tinnitus and hearing impairment. For a huge number of patients, tinnitus is often a leading indicator of hearing loss. These patients tend to seek treatment for tinnitus much earlier than for hearing loss. Therefore I see huge opportunities for Lenire™ to boost the hearing aid retail market.”
Inflazome’s Somalix Demonstrates Positive Safety, Tolerability and Pharmacodynamic Profile in its Phase I Study
Results from the first-in-human study showed excellent safety, tolerability and pharmacokinetics in healthy subjects resulting in target engagment at all doses tested. These results support the progression of Somalix into Phase II studies this year.
Somalix is a potent and selective NLRP3 inflammasome inhibitor under development as an orally available, peripherally-restricted drug for inflammatory diseases.
Dublin (IE), Cambridge (UK), Brisbane (AU) | Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces the successful completion of a Phase I study of its investigational drug, Somalix. Somalix is a small molecule, peripherally-restricted inhibitor of the NLRP3 inflammasome. The Phase I data showed excellent safety and tolerability, while pharmacokinetics showed linear increase with dose which could be correlated with pharmacodynamic response. The results further validate Inflazome’s technology platform and support the progression of Somalix into Phase II clinical trials in the second quarter this year.
Activation of the NLRP3 inflammasome in the body is implicated in many diseases caused by chronic, uncontrolled inflammation. The Phase I study was a first-in-human, single-centre, double blinded and randomised trial that demonstrated excellent safety or tolerability in healthy, adult participants.
Subject to positive Phase I study results, Inflazome also intends to subsequently progress its second investigational drug, Inzomelid, into Phase II studies this year. Inzomelid is an orally available, brain-penetrant small molecule, intended for treatment of debilitating inflammatory diseases of the brain.
Thomas Jung, Chief Medical Officer of Inflazome, commented, “We are very pleased to have progressed our investigational drug, Somalix, through a first-in-human Phase I study and to have demonstrated safety, tolerability and pharmacodynamic response. We can now accelerate Somalix to fulfill its potential through multiple Phase II studies. We are expecting further data read outs for our investigational brain-penetrant drug Inzomelid very soon and look forward to progressing our pipeline to address inflammatory diseases with significant unmet medical need.”
About Inflazome
Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two clinical-stage investigational drugs. Inzomelid is under development as an orally available, brain-penetrant drug and Somalix is under development as an orally available, peripherally-restricted drug. Both will address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.
Inotrem expands Series B financing to €58 Million with a mix of Equity and Debt, adding new investors Fountain Healthcare Partners, Kreos and BPI France
New investor Fountain Healthcare Partners provides a further €5 M capital increase adding on the initial €39 M announced last September
Inotrem also secured a €13 M credit line from Kreos Capital and a €1 M loan from BPI France.
Proceeds will be used to advance the Company’s applications in septic shock and chronic inflammatory diseases.
Inotrem S.A., a biotechnology company specialized in the development of immunotherapies targeting the TREM-1 pathway with potential applications for acute and chronic inflammatory syndromes, announced a €5M capital increase financed by Fountain Healthcare Partners, a leading Irish venture capital firm with offices in Dublin and New York. This fundraising brings Inotrem’s Series B financing to a final closing amount of €44M. In addition, the Company secured a €13M credit line from Kreos Capital, Europe's largest provider of specialty finance to growth companies, and a €1M loan from BPI France, France’s public investment bank.
The financing will support Inotrem’s R&D effort, in particular of its lead drug candidate, nangibotide, which is currently undergoing a global multicentric Phase IIb trial in septic shock patients (ASTONISH trial) in 5 European countries and the United States, and of a companion diagnostic tool aimed at selecting those septic shock patients that are more likely to respond favorably to treatment. Financing will also allow the Company to expand its TREM-1 franchise to address chronic inflammatory diseases.
“With Fountain Healthcare Partners joining our pool of world-class investors, Inotrem is in an ideal position to advance its market-breaking technology platform centered on the TREM-1 pathway and bring new immunotherapies to patients and the medical community” said Jean-Jacques Garaud, CEO of Inotrem.
Based on a novel approach of immunomodulation which targets the TREM-1 pathway, Inotrem has developed a proprietary technology platform and leverages its extensive knowledge of the TREM-1 pathway biology to develop programs in several indications with inflammatory syndromes for which there is a major and today unsatisfied therapeutic need. Its lead compound, nangibotide, targets septic shock which is the ultimate complication of sepsis. The incidence of septic shock continuously raises and mortality remains elevated (35%) in developed countries. There is currently no specific mechanism-based therapy approved for this indication. Inotrem’s solution has the potential to become the first mechanism-based treatment for septic shock.
“Inotrem has demonstrated its ability to reach several critical milestones and we are delighted to back this team. The TREM-1 pathway is extremely compelling and has great potential to bring solutions to patients that today lack effective therapies”, indicated Ena Prosser of Fountain Healthcare Partners.
In conjunction with the financing, Ena Prosser of Fountain Healthcare Partners will become a member of Inotrem’s Board of Directors, and Aris Contantinides of Kreos Capital will become an observer on Inotrem’s Board of Directors.
About Inotrem
Inotrem S.A. is a biotechnology company specialized in immunotherapy for acute and chronic inflammatory syndromes. The company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Through its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, LR12 (nangibotide), with potential applications in a number of therapeutic indications such as septic shock and myocardial infarction. In parallel, Inotrem has also launched another program to develop a new therapeutic modality targeting chronic inflammatory diseases. The company was founded in 2013 by Dr. Jean-Jacques Garaud, a former head of research and early development at the Roche Group, Prof. Sébastien Gibot and Dr. Marc Derive. Inotrem is supported by leading European and North American investors. Inotrem is a FrenchTech120 company: it was chosen to join the program launched by the French President of the Republic and the Prime Minister to support the development of fast growing startups. For more information please visit: www.inotrem.com
About Fountain Healthcare Partners
Fountain Healthcare Partners is a life science venture capital fund with offices in Dublin, and New York. Founded in 2008, Fountain is Ireland’s largest dedicated life science venture capital fund with more than €294 million under management. Fountain invests in entrepreneurs and companies with disruptive technologies or products that have a clear pharmacoeconomic benefit and a defined pathway to commercialisation, value enhancement and exit. Fountain typically leads or co-leads its investments and has sourced private and public deals from start-ups, corporate spin-outs and turnaround situations. The Fountain Healthcare Partners team brings to investees over 70 years of collective experience in the pharmaceutical industry, corporate venture capital and VC across multiple investment and market cycles. For more information please visit: www.fh-partners.com
About Kreos Capital
Kreos Capital is the leading provider of growth-debt financing to high-growth companies in Europe and Israel with revenues up to EUR 300 million. Since 1998, as the pioneer growth debt provider across Europe and Israel, Kreos has completed 540 transactions and committed more than EUR 2.3 billion in 16 different countries. Kreos is dedicated to supporting management teams and their equity investors with flexible loan structures for all stages of a growth company's development and to address the needs for growth capital, working capital, acquisition financings, lower mid-market buy-outs, roll-up strategies, banks re-financings as well as pre- and post-IPO financings. Kreos's most recent fund, EUR 700 million Kreos VI, was launched in January 2019. The Kreos global team has extensive debt financing, management and equity investing experience, covering the markets in Europe and Israel from its locations in London, Tel-Aviv and Stockholm.
Media contact for Inotrem
Anne REIN S&I | STRATEGIES&IMAGE
+33 6 03 35 92 05
Inflazome IP Portfolio Strengthened with Patents Granted in US and Europe
USPTO and EPO grant patents licensed exclusively to Inflazome
Patent claims cover Inflazome’s brain penetrant drug Inzomelid
DUBLIN, Ireland, CAMBRIDGE, United Kingdom & BRISBANE, Australia - Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple small molecule drugs that block harmful inflammation, today announces that the United States Patent and Trademark Office (USPTO) and the European Patent Office (EPO) will grant the patent application WO 2016/131098 as US 10,538,487 on 21 January 2020 and EP 3,259,253 on 15 January 2020.
The patents provide for compounds which have advantageous properties and show useful activity in the inhibition of NLRP3 inflammasome activation. Such compounds are useful in the treatment of a wide range of disorders, including Parkinson’s, Alzheimer’s and Motor Neuron Disease, in which inflammation arising from the NLRP3 inflammasome is implicated as a key factor. Inflazome currently has two ongoing Phase I studies with Inzomelid and Somalix.
These new patents strengthen Inflazome’s intellectual property portfolio that extends to 43 patent families, reinforcing the company’s leading innovative position in discovering targeted therapies for inflammatory-driven diseases.
Matt Cooper, Chief Executive Officer of Inflazome, commented: “The granting of these pioneering patents marks another milestone for Inflazome and strengthens our IP portfolio. The patents granted in the US and Europe cover our lead clinical candidate, Inzomelid. Both Inzomelid and our second drug, Somalix, are in the final stages of Phase I safety and tolerability trials for inflammatory diseases. We look forward to driving these drugs into further trials to help people with debilitating diseases.”
The patent was originally filed by the University of Queensland and Trinity College Dublin following a highly productive collaboration between Inflazome founders, Professor Matt Cooper (University of Queensland) and Professor Luke O’Neill (Trinity College Dublin). It was licensed exclusively to Inflazome when the company was founded.
About Inflazome
Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two ongoing Phase I studies, the first with Inzomelid which is under development as an orally available, brain-penetrant drug, and the second with Somalix which is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia. To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.
Contacts
Inflazome: Dr Jeremy Skillington | VP Business Development E: j.skillington@inflazome.com
Media: FTI Consulting: UK & International | Ciara Martin/Tim Stamper T: +44 20 37271000 Ireland & International | Jonathan Neilan/Patrick Berkery T: +353 1 7650800 E: StratCommEMEAInflazome@fticonsulting.com
KaNDy Therapeutics Announces Positive Phase 2b Data in Post-Menopausal Women with its Lead Non-Hormonal Product NT-814
Phase 2b dose range finding study showed rapid and highly significant reductions in the frequency of hot flashes (primary endpoint) for the full 12-week treatment period
Reduction in hot flashes was associated with statistically significant improvements in quality of life, mood and sleep – all key secondary endpoints
All doses of NT-814 were well tolerated during the study, demonstrating a safety profile that supports progression to Phase 3 ~
Stevenage, UK – KaNDy Therapeutics, a UK clinical-stage biotech company, today announces positive data from the Phase 2b “SWITCH-1” clinical trial with its lead non-hormonal drug candidate, NT-814, for the treatment of symptoms of the menopause.
Following on from the clear benefits NT-814 demonstrated in the Phase 2a RELENT-1 study, the SWITCH-1 trial provides further compelling evidence that NT-814, a first in class, once-daily, oral neurokinin-1,3 receptor antagonist, can produce a rapid and marked reduction in the most troublesome and frequent symptoms of the menopause, hot flashes and night sweats (vasomotor symptoms). The clinical relevance of the marked improvements shown on the vasomotor symptom endpoints was supported by highly statistically significant improvements across patient reported assessments of quality of life, mood and sleep.
The SWITCH-1 study was a randomised, double-blind, placebo-controlled trial conducted in the US, UK and Canada. One hundred and ninety-nine women experiencing at least 7 moderate or severe hot flashes/flushes (HF) per day were recruited into the study and randomised to receive one of four doses of NT-814 or placebo. Treatment with NT-814 once daily for 12 weeks at the most effective dose evaluated resulted in:
Statistically significant reductions compared to placebo in average hot flash frequency (primary endpoint), starting during the first week of treatment and continuing throughout the 12-week treatment period. Least squares mean reductions in average hot flash frequency were -6.7 for NT-814 vs -2.7 for placebo at week 4, and -7.8 vs -4.7 at Week 12 (p<0.0001 and p=0.0092, respectively).
Marked improvements in all key secondary endpoints: improved quality of life was shown by highly significant improvements over placebo in the MenQoL menopause-specific quality of life scores, benefits on mood were demonstrated by significant improvements in the Beck Depression Inventory (II), and improved quality of sleep was shown by statistically significant improvements compared to placebo in the Pittsburgh Sleep Quality Index scores.
NT-814 was well tolerated across the dose range with a safety profile that supports progression to Phase 3.
Dr. James A. Simon, Clinical Professor of Reproductive Endocrinology & Infertility at George Washington University, and the study’s Lead Investigator, commented: “These top-line results of the SWITCH-1 study are very exciting. They demonstrate that NT-814, a truly novel therapy, offers a rapidly effective, non-hormonal approach to treating menopausal hot flashes and night sweats, debilitating symptoms of menopause. Unique to this trial, patients also reported improvements in quality of life, mood and sleep with NT-814.”
Dr Mary Kerr, Co-Founder and CEO KaNDy Therapeutics, said: “The SWITCH-1 study started in November 2018, and so we are excited to share such positive results on schedule. The data confirms and validates Phase 2a observations, providing more evidence that neurokinins are fundamental to sex hormone biology and the pathophysiology of the menopause, resulting in almost immediate symptom relief. The Company looks forward to presenting these data at future scientific meetings and discussing it with regulatory agencies in advance of progressing the compound into pivotal registration studies.”
For more information, please contact:
KaNDy Therapeutics
Email: info@kandytherapeutics.com
Consilium Strategic Communications
Mary-Jane Elliott/ Lindsey Neville/ Carina Jurs
Tel: +44 (0) 20 3709 5700
KaNDyTherapeutics@consilium-comms.com
About the SWITCH-1 Study:
The Phase 2b SWITCH-1 study was a randomised, double-blind, placebo-controlled study conducted at 25 sites in the UK, US and Canada. It included an adaptive randomisation design that enabled the randomisation ratio to be modified to focus on doses of greatest interest based on emerging data. The study was initiated in November 2018 and completed, ahead of schedule, at the end of 2019. A total of 199 post-menopausal women experiencing at least 7 moderate or severe HFs per week were recruited into the study and randomized to receive one of four doses of NT-814 or placebo. Study drug was taken once daily in the evening for 12 weeks. Subjects completed electronic diaries twice daily for the two weeks before and throughout treatment and underwent routine safety assessments periodically throughout the trial. Patient reported assessments of sleep, quality of life and mood were also completed periodically during study visits. Further information on the study design can be found on www.clinicaltrials.gov and full results of the study will be published at scientific congresses and in peer-reviewed journals over the coming months.
NT-814 is an orally administered, potent and selective small molecule dual antagonist of both the neurokinin-1 and 3 receptors under development by KaNDy as a therapy for a range of Women’s Health conditions. NT-814 addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurones in the hypothalamus in the brain (the KNDy neurones), that in menopausal women due to the absence of oestrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hot flashes and night sweats.
KaNDy Therapeutics is a clinical-stage company focused on optimizing the potential of NT-814 in the treatment of common, chronic debilitating female sex-hormone related conditions. These conditions, such as post-menopausal vasomotor symptoms, are debilitating for women often over many years and associated with significant healthcare and economic costs. NT-814 is wholly owned by KaNDy.
Syndesi Therapeutics announces the expansion of its management team with the appointment of Torsten Madsen, MD, PhD as Chief Medical Officer
Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced Torsten Madsen MD, PhD has joined its management team as Chief Medical Officer.
Dr. Madsen brings over 12 years’ industry experience in CNS drug development in pharma/biotech. As a senior leader at Lundbeck in Denmark and the US he guided clinical development and registration of the anti-depressant vortioxetine. More recently, he has held senior roles at the CNS focused biotech companies Naurex and Aptinyx. Dr. Madsen earned his MD and a PhD from Copenhagen University, doing clinical training in psychiatry and general medicine and holding a postdoc position at Yale, conducting basic research in neural and synaptic plasticity.
Commenting on the appointment, Jonathan Savidge, CEO of Syndesi, said, “I’m delighted to welcome Torsten to the Syndesi team at an exciting time for the development of our lead molecule SDI-118. Torsten brings a wealth of experience specifically in CNS drug development and this will be invaluable to the company as we plan the next phases of clinical development for SDI-118.”
On his appointment as CMO, Torsten Madsen said, “It’s very exciting to be joining Syndesi to work on a novel synaptic mechanism with potential for broad applicability for treatment of cognitive impairment. I look forward to working with the Syndesi management team to progress SDI-118 into the next stage of clinical development to fully explore its potential to improve symptoms of cognitive impairment across a range of indications.”
About Syndesi Therapeutics
Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The company has raised a total €17M in Series A funding from a syndicate of Belgium and international investors and has been awarded a total of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI-118. For more information please visit www.syndesitherapeutics.com.
Mainstay Medical Announces Completion of Day 100 Meeting with FDA Regarding Pre-Market Approval (PMA) Application for ReActiv8
Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), a medical device company focused on bringing to market ReActiv8, an implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain, today announced that on 10 December 2019 the Company completed a Day 100 meeting with the U.S. Food and Drug Administration (FDA) regarding a Pre-Market Approval (PMA) application submission for ReActiv8.
Jason Hannon, CEO of Mainstay, said: “We appreciate the opportunity to meet with FDA to discuss their review of the data we included in the PMA. The productive dialogue will help us submit an amendment to the PMA to reflect FDA’s feedback. We continue to expect a decision regarding approval around the end of 2020.”
FDA generally meets with the PMA sponsor approximately 100 days after filing of the PMA for the purpose of discussing the status of the review of the application. Prior to the meeting, FDA provided Mainstay with its initial feedback on the PMA, consisting of questions regarding the data included in the PMA and the interpretation of such data. The Company currently has no plans to conduct another premarket pivotal IDE trial for ReActiv8.
Mainstay will include the information requested by FDA in an amendment to the PMA, which the Company expects to file in the first quarter of 2020.
Mainstay Medical Announces Regulatory Approval from Australian Therapeutic Goods Administration (TGA) for ReActiv8
Application for inclusion on Australian Prostheses List for private reimbursement planned for first quarter of 2020, with an approval decision expected in the third quarter of 2020.
Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth operated by Euronext Dublin (MSTY.IE), today announced that it has received regulatory approval from the Australian Therapeutic Goods Administration (TGA) for ReActiv8, its implantable restorative neurostimulation system to treat disabling Chronic Low Back Pain. This approval confirms admission of ReActiv8 to the Australian Register of Therapeutic Goods (ARTG), enabling commercialization throughout Australia.
Jason Hannon, CEO of Mainstay, said: “We are excited to receive TGA approval and take the next step toward making ReActiv8 available to patients in Australia. Australian physicians who have been part of our clinical studies to date are among the most experienced globally in selecting and treating patients with ReActiv8 therapy. The clinical data in support of ReActiv8 continues to build and was instrumental in demonstrating to TGA that ReActiv8 is a valuable therapy that should be available to Australian patients. This approval was received ahead of our expected timeline, and we will now move to the next step in the process, which is applying for inclusion of Reactiv8 on the Prostheses List. We plan to launch ReActiv8 commercially after securing a place on the Prostheses List.”
The Company plans to submit an application for ReActiv8 to be included in the Prostheses List of reimbursed products, with a reimbursement decision expected in the third quarter of 2020. The Prostheses List identifies implantable devices eligible for reimbursement from all private health insurance funds in Australia.
About ReActiv8
ReActiv8 is an active implantable medical device designed to treat people with chronic low back pain (CLBP). ReActiv8 electrically stimulates the nerves that supply the lumbar multifidus muscle, a key stabilizing muscle of the low back, to elicit contraction of the muscle which can lead to restoration of control over time, allowing the back to recover from CLBP.
Low back pain is the number one cause of years lived with disability worldwide and is a leading cause of activity limitation and work absence throughout much of the world, imposing a high economic burden on individuals, families, communities, industry, and governments. While treatment options exist for patients with CLBP of a predominantly neuropathic origin, for the large portion of patients whose pain is predmoniantly nociceptive (or mechanical) in nature there are few therapies beyond drugs and injections, both of which offer temporary relief at best.
ReActiv8 is intended for those patients without indications for spine surgery or spinal cord stimulation and who have continuing pain despite medical management. The Company estimates that there are approximately two million people in the EU and the U.S. alone who could be candidates for ReActiv8 today.
ReActiv8 has a CE Mark allowing for commercialization in the European Economic Area and has been focused on building clinical validation in Germany in select centers ahead of wider commercial availability in the future. The Company submitted the final module of its Pre-Market Approval (PMA) application to the U.S. FDA relating to ReActiv8 in August 2019, and it expects an approval decision around the end of 2020.
Inflazome Progresses Two Drugs Into Clinical Trials
Two Phase I studies are underway for Inzomelid and Somalix, Inflazome’s NLRP3 inflammasome inhibitors, with data due in Q1 2020
Inzomelid is under development as an orally available, brain-penetrant drug for neuroinflammatory diseases such as Parkinson’s, Alzheimer’s and Motor Neuron Disease as well as orphan diseases such as CAPS (Cryopyrin-associated periodic syndromes)
Somalix is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions such as arthritis and cardiovascular disease
Inflazome (inflazome.com), the pioneering inflammasome biotech company developing multiple drugs that stop harmful inflammation, today announces that healthy volunteers have been successfully dosed in the company’s Phase I clinical trials of Inzomelid and Somalix, two small molecule inhibitors of the NLRP3 inflammasome. These trials represent an important milestone for Inflazome and confirm its leadership in the inflammasome space.
Activation of the NLRP3 inflammasome in the body drives harmful inflammation, and is implicated in many diseases. Inzomelid and Somalix are two potent small molecules designed to inhibit activation of NLRP3 and reduce the damage caused by chronic, uncontrolled inflammation.
Inzomelid is a brain-penetrant drug intended for the treatment of neuroinflammatory and neurodegenerative diseases such as Parkinson’s, Alzheimer’s and Motor Neuron Disease as well as the orphan disease CAPS.
Somalix is intended for the treatment of debilitating conditions such as cardiovascular disease, arthritis and many other diseases.
Both Phase I studies are first in human, single-centre, double blinded, randomised trials and are designed to evaluate safety and tolerability in healthy adult participants. The Inzomelid trial is expected to complete in January 2020, whilst Somalix will complete in March 2020. The Company intends to progress Inzomelid and Somalix into multiple Phase II studies in 2020.
Thomas Jung, Chief Medical Officer of Inflazome, commented, “We are delighted to see our two leading candidates, Inzomelid and Somalix, progress into the clinic and take a step closer towards finding a treatment for patients suffering from a range of diseases caused by harmful inflammation.”
Matt Cooper, Chief Executive Officer of Inflazome, commented, “This achievement represents an important milestone for Inflazome and for the field of inflammatory diseases more generally. We are excited to advance two drugs into safety trials in preparation for multiple proof of concept Phase II trials in 2020. We have pioneered the development of inhibitors of inflammasome-driven inflammation and will use our expertise to bring benefits to patients as quickly as possible.”
About Inflazome
Inflazome is a biotech company leading the development of orally available drugs to address clinical unmet needs in inflammatory diseases by targeting inflammasomes. Inflammasomes are understood to drive many chronic inflammatory conditions, from Parkinson’s and Alzheimer’s to asthma, inflammatory bowel disease, chronic kidney disease, cardiovascular disease, arthritis and NASH. Inflazome has two ongoing Phase I studies, the first with Inzomelid is under development as an orally available, brain-penetrant drug for neuroinflammatory diseases such as Alzheimer’s, Parkinson’s and Motor Neuron Disease. Somalix is under development as an orally available, peripherally-restricted drug to address clinical unmet needs in inflammatory conditions such as arthritis and cardiovascular disease. Inflazome is headquartered in Dublin, Ireland, with offices in Cambridge, UK and Brisbane, Australia.
To learn more visit: inflazome.com
About the NLPR3 Inflammasome
Activated NLRP3 acts as a ‘danger sensor’ in the body to release the pro-inflammatory cytokines IL-1β, IL-18 and induce uncontrolled, lytic cell death (pyroptosis). These processes lead to chronic inflammation, and as such, NLRP3 has been implicated in a large number of diseases.
Contacts
Inflazome: Dr Jeremy Skillington | VP Business Development
E: j.skillington@inflazome.com
Media: FTI Consulting
UK & International | Ciara Martin/Tim Stamper
T: +44 20 37271000
Ireland & International | Jonathan Neilan/Patrick Berkery
T: +353 1 7650800
Syndesi Therapeutics announces successful completion of first-in-human Phase I study of novel SV2A modulator, SDI-118, in development for the treatment of cognitive impairment
Syndesi Therapeutics SA, a biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, today announced that the first-in-human Phase I study of its lead molecule, SDI-118, has been successfully completed.
The first-in-human Phase I study was a randomized, placebo controlled, single ascending dose study in healthy male subjects designed to investigate the safety, tolerability and pharmacokinetics of oral doses of SDI-118. The study also included PET imaging in a group of subjects to directly measure SV2A target engagement by SDI-118 in the brain.
SDI-118 was safe and well tolerated at all doses administered, with no serious adverse events. All adverse events considered to be related to SDI-118 administration were reported as mild. SDI-118 also showed favorable pharmacokinetic properties suitable for once daily dosing. Data from PET imaging following administration of a range of SDI-118 doses demonstrated a clear relationship between central SV2A occupancy and plasma exposure. Importantly, these results also demonstrated that the plasma exposures reached in the study, shown to be safe and well tolerated, provided essentially complete brain SV2A occupancy.
Commenting on the results, Jonathan Savidge CEO of Syndesi, said “We are very pleased with the excellent data generated in this first-in-human study. Single doses of the compound that result in high SV2A occupancy were shown to be safe and well tolerated. The results of the study provide an excellent basis for further clinical development, with the PET data informing the choice of doses in future studies. We will be initiating a further Phase I trial investigating multiple doses of SDI-118, including in elderly subjects.”
About Syndesi Therapeutics
Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. In February 2018 the company announced €17M in Series A funding from a syndicate of Belgium and international investors. In March 2019, Syndesi announced the award of up to €3.2 M in non-dilutive funding from the Walloon Region to support the development of the lead molecule SDI-118 through Phase I clinical development. Syndesi is investigating the potential of these novel SV2A modulators to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well other conditions such as major depression and cognitive impairment associated with schizophrenia. For more information please visit www.syndesitherapeutics.com
Mainstay Medical Announces Acceptance For Filing by US FDA Of Pre-Market Approval (PMA) Application for ReActiv8
Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth of Euronext Dublin: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain, today announces that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Pre-Market Approval (PMA) application for ReActiv8.
Mainstay submitted the PMA to the FDA in August. By regulation, the FDA will notify the applicant whether the PMA has been accepted for filing within 45 days after submission. By accepting the Company’s PMA for filing, the FDA has made a threshold determination that the application is sufficiently complete to begin an in-depth review. Mainstay continues to expect a decision on approval around the end of 2020.
About Mainstay
Mainstay is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and is listed on regulated market of the Euronext Paris (MSTY.PA) and the Euronext Growth market of Euronext Dublin (MSTY.IE).
About Chronic Low Back Pain
One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.
Further information can be found at www.mainstay-medical.com
CAUTION – in the United States, ReActiv8 is limited by federal law to investigational use only.
Neuromod Successfully Closes €8 Million Capital Raise
Proceeds to accelerate ongoing European commercialisation, manufacturing scale-up and US regulatory strategy
Fountain Healthcare Partners, a major investor, led the financing round with participation from another existing investor, Moffett Investment Holdings
Venture-debt investors Kreos Capital and Silicon Valley Bank also participated in the capital raise
Neuromod Devices Limited (“Neuromod” or the “Company”), the Irish medical technology company specialising in non-invasive neuromodulation technologies, today announces the closing of an €8 million capital raise, comprised of equity investment and venture-debt.
Proceeds from the financing will be used to accelerate ongoing European commercialisation of the Company’s Lenire® tinnitus treatment device; to scale-up manufacturing capacity to meet anticipated European demand; and to progress the Company’s US regulatory strategy to secure market entry into the United States. This financing round was led by existing investors Fountain Healthcare Partners and Moffett Investment Holdings, with venture-debt provided by new investors Kreos Capital and Silicon Valley Bank.
Centre of Excellence in Tinnitus Care and Neuromodulation
This investment marks a significant milestone for Neuromod as the Company recently opened its first Centre of Excellence specialising in neuromodulation and tinnitus at the Hermitage Medical Clinic in Dublin. The centre, Neuromod Medical, a wholly-owned subsidiary of Neuromod Devices Limited, offers tinnitus assessments and treatment with the Lenire® tinnitus treatment system, a breakthrough evidence-based, home-use medical device. The first facility to offer treatment with Lenire® outside of Ireland will be in Hannover, Germany which will be opened before the end of 2019. Additional locations throughout Europe have been identified and will become operational during the course of 2020.
Lenire® Tinnitus Treatment
Lenire® is the first non-invasive bimodal neuromodulation tinnitus treatment shown to soothe and relieve tinnitus. Lenire® has CE-mark certification for the treatment of tinnitus under the supervision of an appropriately qualified healthcare professional in Europe.
Dr. Ross O’Neill, CEO of Neuromod commented: “We are very pleased to have Kreos Capital and Silicon Valley Bank join our existing investors Fountain Healthcare Partners and Moffett Investment Holdings. This investment will allow us to ramp-up the manufacturing of our Lenire® tinnitus treatment product, ensuring it will be more widely available for many underserved patients suffering with tinnitus across Europe. We will also build on European commercialisation through a regulatory submission to the FDA to make way for a launch in the United States”.
Cian O’Driscoll from Kreos Capital commented: “Neuromod is an exceptional business with a unique technology and product. We are excited to be working with them to fund their expansion across Europe and the United States. It is estimated that 150 million people suffer with chronic tinnitus globally and we believe Lenire® offers an important breakthrough to address this large unmet medical need”.
Clive Lennox from Silicon Valley Bank commented: “We are delighted to join Fountain Healthcare and Moffett Investments to support the growth of Neuromod Devices. Neuromod are yet another example of Ireland’s innovative life-science companies and we look forward to helping them bring their Lenire® tinnitus treatment to the millions of sufferers across Europe and the US.”
Dr Manus Rogan, Managing Partner of Fountain Healthcare Partners, commented: “As an early stage investor in Neuromod, we are excited to be at a point where we are ramping up manufacturing and European commercialisation of Lenire® and looking towards US regulatory filing. The market potential for Neuromod and Lenire® is clearly significant necessitating investment in manufacturing sufficient inventory to meet the existing and anticipated demand.”
About Neuromod Devices Limited
Neuromod, headquartered in the Digital Hub, Dublin, Ireland, is an emerging medical technology company, specialising in the design and development of neuromodulation technologies to address the clinical needs of underserved patient populations who live with chronic and debilitating tinnitus. The company was founded in 2010, by Dr. Ross O’Neill, as a spin-out from Maynooth University.
Neuromod has conducted the largest and longest followed-up clinical trials in tinnitus to confirm the efficacy of its non-invasive neuromodulation treatment device for this extremely common disorder for which no standard of care has yet been established. Tinnitus affects between 10 and 15% of the global population, and the lives of at least 1 in every 100 people worldwide are severely compromised because of the incessant nature of the illusory sound that is often described as a ringing or buzzing in the ears.
Contacts
Patrick Berkery
+353-1-765-0884
EIB unveils financing for Irish innovation as Galway medtech firm Vivasure Medical gets EUR 10 million backing
Vivasure Medical second Irish medtech firm to get EIB Venture Debt financing
EIB and IBEC brief business leaders on new long-term financing for Irish innovation
EIB confirms strengthened direct support for Irish companies
Galway based Medtech Company Vivasure Medical Ltd. is the latest Irish company to agree Venture Debt financing with the European Investment Bank.
The second long-term EIB financing for an Irish medical technology company was confirmed ahead of a briefing for Irish business leaders on new innovation financing opportunities supported by the EU Bank.
IBEC-EIB briefing on new innovation financing opportunities
Company representatives and innovation partners were briefed on new tailor made EIB financing at workshop in Dublin hosted by IBEC and the EIB, part of a series of corporate finance briefings being held across Ireland.
“Ireland is home to world class innovation and the European Investment Bank recognises the crucial need to ensure that research driven companies can expand and succeed in new markets. The new EUR 10 million backing for Vivasure Medical will contribute to efforts to improve cardiology and endovascular treatment through pioneering medtech innovation. In partnership with IBEC we wish to ensure that companies across Ireland can consider how streamlined innovation financing can turn research ideas into commercial success.” said Andrew McDowell, European Investment Bank Vice President.
“Access to diversified funding streams help boost the competitiveness, resilience and innovation of fast growing companies in Ireland. Companies across Ireland are securing EIB financing, allowing them to continue to develop, innovate and compete on a global level. Today’s joint event with the EIB allows companies across a range of sectors to gain a direct insight into new innovation financing at our fourth specialist finance briefing” said Danny McCoy, Ibec CEO.
Over the last three years research focussed companies across Ireland have benefited from European Investment Bank Venture Debt financing. These include world class companies developing artificial intelligence, pharmaceutical and telecommunication products.
Expanding development of cardiology treatment for high risk patients
The EUR 10 million new financing will be used by Vivasure to expand research and development of medical devices to provide non-invasive cardiology treatment. Vivasure has developed pioneering non-invasive biodegradable devices to treat cardiology patients with conditions that require vascular surgery.
“Over the last decade Vivasure Medical has developed innovative and easy to use medical devices that transform cardiology and endovascular treatments and avoid the need for access and closure surgery. We welcome the European Investment Bank’s firm support and agreement of EUR 10 million of new financing that will enable Vivasure to accelerate innovation and expand into new markets. This is a vote of confidence in the Irish Medtech.” said Gerard Brett, CEO and co-founder of Vivasure Medical.
Last year the European Investment Bank Group provided EUR 970 million of long-term financing to strengthen higher education, improve healthcare, transform transport and harness clean energy across Ireland, as well as enhancing corporate research and innovation.
Mainstay Medical Provides Company Update and Reports 2019 Half Year Financial Results
ReActiv8 Pre-Market Approval (PMA) application submitted to U.S. FDA in August 2019; acceptance for FDA review expected October 2019
European commercial validation efforts continue to progress
Successful completion of financing transactions providing approximately $28 million of cash runway extension
Mainstay Medical International plc (“Mainstay” or the “Company”, Euronext Paris: MSTY.PA and Euronext Growth of Euronext Dublin: MSTY.IE), a medical device company focused on bringing to market ReActiv8®, an implantable neurostimulation system to treat disabling Chronic Low Back Pain, today provides a company update and reports its financial results for the half year ended 30 June 2019.
Jason Hannon, CEO of Mainstay, said: “We continue to make significant progress on our key corporate objectives of pursuing regulatory approval in the U.S. and advancing the commercial validation effort in Germany and other select European markets. I am pleased to report that we submitted the pre-market approval (PMA) application for ReActiv8 to the U.S. Food and Drug Administration (FDA) in August. Pending the FDA’s acceptance of the PMA for review, anticipated in October 2019, we expect a decision regarding approval around the end of 2020. We also continue to make progress working with key physician partners in Germany who are incorporating ReActiv8 into their practices in order to validate commercial adoption, refine patient selection strategies and follow ongoing patient progress.”
Business Update
In August 2019, Mainstay submitted the PMA application to the FDA based upon the totality of its clinical data for ReActiv8. Pending acceptance of the submission by the FDA, anticipated in October 2019, a decision regarding approval is expected around the end of 2020. The pivotal clinical trial upon which the PMA submission was based is the 204-patient ReActiv8-B clinical study. A summary of the clinical trial results is as follows:
The primary efficacy endpoint of the study was a comparison of responder rates between the treatment and control groups as measured on the visual analog scale (VAS) of pain, with responders defined as having a 30% or greater improvement on this measure between baseline and 120 days after randomization, without any increase in pain medication and/or muscle relaxants taken in the two weeks prior to the primary endpoint assessment visit. In the treatment group the responder rate at 120 days was 57%, compared to 47% in the control group, resulting in a difference that is not statistically significant.
The protocol included a pre-specified analysis of the primary endpoint data examining the cumulative proportion of responders, which is a comparison of ranks and inherently preserves information over a dichotomized endpoint, thereby improving statistical power. In that analysis, a statistically significant difference between the treatment and control groups was demonstrated, with the treatment group showing a higher proportion of responders across all threshold levels.
The protocol also included a pre-specified analysis of the primary endpoint where Mainstay adjusted for patients who increased their pain medications for reasons unrelated to their back pain. In that analysis, the responder rate at 120 days in the treatment group was 61%, compared to 47% in the control group, resulting in a difference that is statistically significant.
Statistically significant differences on a number of key secondary endpoints and supplemental analyses were observed in the treatment group as compared to the control group at 120 days, including reduction from baseline in pain as measured by both mean reduction in VAS and percent of pain relief (PPR), change from baseline in disability measured by the Oswestry Disability Index (ODI), change from baseline in quality of life measured by the European Quality of Life Score on Five Dimensions (EQ-5D), subject global impression of change (SGIC), clinician global impression of change (CGI) and patient treatment satisfaction as measured by the treatment satisfaction questionnaire (TSQ).
Improvements in the percentage of patients reporting pain reduction continued beyond the 120-day assessment through one year for both groups. The percentage of the 160 patients in the treatment and control groups that had completed the one-year assessment having a 30% or greater reduction in low back pain VAS at that assessment without a significant increase in pain medication was 66%. These data are subject to change as the remaining patients reach the one-year assessment.
The protocol permitted patients to adjust their back pain medication usage after the 120-day assessment point. At one year, 49% of the 61 patients in both groups combined who were on opioids at baseline had discontinued or decreased their use of opioids. These results are subject to change as the remaining patients reach the one-year assessment.
The incidence and type of adverse events (AEs), including serious AEs, compares favorably to that of spinal cord stimulator devices, with no unanticipated AEs related to the device, procedure or stimulation.
In Germany, Mainstay’s initial European market, the Company’s re-focusing of its commercial validation efforts was undertaken throughout 2018. Mainstay is now solely dedicated to building a small number of reference sites where high volumes of patients are treated with ReActiv8, allowing the Company to gather associated clinical data, refine patient selection processes for commercial markets, and gain the learnings needed to accelerate commercial launch in future markets.
Financial Update
Since the beginning of 2019, Mainstay has conducted financing activities that have resulted in approximately $28 million of cash runway extension:
On 29 July 2019, Mainstay completed financing transactions consisting of the issuance of 4,649,775 new ordinary shares at a purchase price of €3.00 per share and the drawdown of €3.0 million in additional debt from the Company’s existing lender, IPF Partners, resulting in aggregate gross proceeds of €16.9 million (US$18.9 million).
On 18 April 2019, Mainstay and its subsidiary, Mainstay Medical Limited, entered into an amendment to their agreement with IPF Partners relating to the existing debt facility. Pursuant to the amendment:
The repayment schedule for the three existing tranches drawn under the debt facility was amended such that no principal or interest will be repaid until 2021, with the principal and accrued interest to be amortized over the period from January 1, 2021 through September 30, 2023.
A new tranche of €3.0 million (approximately $3.34 million) was made available to Mainstay, which was drawn down by Mainstay on 29 July 2019. The repayment schedule for the new tranche will be the same as the amended repayment schedule for the three existing tranches.
The interest rate for all tranches will be 8% per annum, with interest accruing but capitalized prior to January 1, 2021. The interest rates previously applicable to the initial three tranches ranged from 10.5% to 12.5%.
The 5% repayment fee applicable to each existing tranche was eliminated.
All principal and accrued interest from all tranches will automatically convert into ordinary shares of the Company at a price per share of €8 upon the earlier of (a) FDA approval of Mainstay’s PMA application for ReActiv8, (b) the date by which at least 900,000 ordinary shares of the Company are publicly sold on-market by non-affiliates of Mainstay since April 2019 at a price per share of at least €8, or (c) IPF Partners’ election to undertake such conversion, in each case unless the Company elects to satisfy such obligation in whole or in part in cash.
The minimum cash covenant was amended so that Mainstay is required to hold cash at least equal to its projected cash expenditures for operations and debt repayment for the next three months, and the covenant relating to the achievement of commercial milestones was eliminated.
Mainstay issued to IPF Partners warrants to purchase 1.5 million of its ordinary shares at a price per share of €6 at any time prior to the 6th anniversary of the amendment date.
Revenue during the six-month period ended 30 June 2019 was $0.6 million ($0.36 million in 1H18).
Operating expenses for the six-month period ended 30 June 2019 were $9.5 million ($15.8 million in 1H18). The decrease was driven primarily by reduced costs relating to activities for the ReActiv-8 B clinical trial following the completion of all implants, as well as a decrease in payroll related costs following a reduction in headcount within 2019.
Cash on hand as at 30 June 2019 was $5.8 million (31 December 2018: $29.7 million). Cash on hand at 31 July 2019 was $23.5 million.
Details of ReActiv8-B Clinical Trial
The ReActiv8-B clinical trial is an international, multi-center, prospective, randomized, active sham-controlled, blinded trial with one-way cross-over, conducted under an IDE from the FDA. A total of 204 patients with chronic low back pain refractory to physical therapy were implanted with ReActiv8 at leading clinical sites in the U.S., Europe and Australia and randomized 1:1 to therapy or control. In the treatment group, the ReActiv8 pulse generator was programmed to deliver electrical stimulation expected to elicit episodic contractions of the multifidus muscle. In the control group, the ReActiv8 device was programmed to provide a low level of electrical stimulation. Following assessment of the primary endpoint at 120 days, patients in the control group crossed-over to receive levels of electrical stimulation similar to those in the treatment group. The FDA’s review of the PMA may result in the FDA not agreeing with Mainstay’s interpretation of its clinical data, including whether statistical significance was achieved for one or more endpoints.
About Mainstay
Mainstay is a medical device company focused on commercializing an innovative implantable restorative neurostimulation system, ReActiv8®, for people with disabling Chronic Low Back Pain (CLBP). The Company is headquartered in Dublin, Ireland. It has subsidiaries operating in Ireland, the United States, Australia, Germany and the Netherlands, and is listed on regulated market of the Euronext Paris (MSTY.PA) and the Euronext Growth market of Euronext Dublin (MSTY.IE).
About Chronic Low Back Pain
One of the root causes of CLBP is impaired control by the nervous system of the muscles that dynamically stabilize the spine. ReActiv8 is designed to electrically stimulate the nerves responsible for contracting these muscles to improve dynamic spine stability, allowing the body to recover from CLBP.
People with CLBP usually have a greatly reduced quality of life and score significantly higher on scales for pain, disability, depression, anxiety and sleep disorders. Their pain and disability can persist despite the best available medical treatments, and only a small percentage of cases result from an identified pathological condition or anatomical defect that may be correctable with spine surgery. Their ability to work or be productive is seriously affected by the condition and the resulting days lost from work, disability benefits and health resource utilization put a significant burden on individuals, families, communities, industry and governments.
Further information can be found at www.mainstay-medical.com